1. The Field of the Invention
The present invention relates generally to devices used to implement various medical procedures. More particularly, embodiments of the present invention relate to an improved valve for use in flushing medical devices and for facilitating the performance of various diagnostic, analytic, therapeutic, and other procedures.
2. The Relevant Technology
In the medical field, tubes and catheters are used in a wide variety of applications including drainage procedures or applications. In these type of applications, the tubes or catheters are of the type which carry various bodily fluids, including but not limited to, abscess fluids, urinary fluids, and biliary fluids. One purpose of such tubes or catheters is to decompress, relieve, or drain a specific collection of fluid from a patient. The expressed fluid is amassed into a collection bag for evaluation or evacuation.
It is important that the interior passageway, or lumen, in drainage tubes and catheters remain unobstructed and that materials such as particulates and/or residues not be allowed to collect or build up on the surface of the lumen in the catheter or tube. The buildup of particulates and/or residues on the interior surface of the lumen in the tube or catheter may lead to uneven, reduced, or obstructed flow. Obstructed, limited, or even uneven fluid flow may extend the recovery time of a patient, resulting in the potential for further complications or infections. For example, an obstructed catheter could cause an infection in the patient that may result, in some cases, in the sickness or even death of the patient. These problems are exacerbated in situations where catheters or tubes which are kept in place for longer periods of time.
In order to avoid such problems, the tubes or catheters must be periodically flushed to ensure that there is not a build-up of particulates or residue in the lumen that could block or otherwise impede the flow of fluid out of the patient. In general, the flushing procedure typically involves attaching a source of flushing, or cleansing, fluid, such as a saline solution, and directing the cleansing fluid under low pressure through the tube or catheter to remove any buildup occurring in the lumen. The fluid is then allowed to flow out the tube or catheter into a drainage bag.
When it is desired to flush the tube or catheter, the drainage bag must be disconnected and the source of cleansing fluid, usually a syringe, is attached to the tube or catheter that is fluidly connected to the patient. Once the cleansing fluid has been directed into the tube or catheter, the syringe or other source of cleansing fluid, must be disconnected and the drainage bag reattached. This procedure is particularly unsatisfactory because of the time required to unscrew the drainage bag, attach the syringe, and then to unscrew the syringe and reattach the drainage bag. In addition, after the cleansing fluid has been directed into the tube or catheter that is attached to the patient, there is an enhanced risk of fluid leakage during the detachment and reattachment process. Such leakage can cause an unsanitary condition and may potentially expose medical personnel and the patient to contamination. Further, if any fluid is accidentally discharged during this process, the medical personnel must take the time to sanitize the patient, the bedding, and themselves.
Another device, commonly referred to as a stopcock, can be used to make the flushing procedure somewhat easier for medical personnel and to reduce the risk of contamination and spillage. The stopcock is attached to the tube or catheter that is in fluid communication with the patient, and thereby connects the tube or catheter to the drainage bag. Typically, the stopcock includes a valve that must be manually operated so that the flow of fluid is directed either into a drainage bag or to an outside port for periodic catheter maintenance or flushing. This allows the fluid source, such as a syringe, to be attached to the outside port when it is time to flush the tube or catheter. Once the syringe is attached, the stopcock is manually adjusted so as to stop the flow of fluid to the drainage bag. This operation allows the cleansing fluid to be directed into the tube or catheter. Once all the cleaning fluid is in the tube or catheter, the stopcock is manually adjusted back to its original position, wherein fluid is allowed to flow into the drainage bag.
While the stopcock represents somewhat of an improvement over the manual flushing procedure, there have been various problems with the stopcock. For example, stopcocks have failed from usage or have had certain limitations to their use. One of the problems with using a stopcock is that the nurse or attendant must manually adjust the stopcock to cease the flow of fluid in the drainage catheter, and then open the access port to enable the flushing fluid to be directed into the lumen of the tube or catheter. Once the cleansing fluid has been directed into the tube or the catheter, the stopcock must again be manually adjusted to redirect the fluid flow into the drainage bag. These extra steps are time consuming and cumbersome.
There is also a possibility that the manual adjustments that are required may confuse the medical personnel so that the fluid flow out of the patient is misdirected. In addition, if for some reason, the medical personnel fail to return the stopcock to the original position, so as to allow the fluid to flow to the drainage bag, fluid will flow out the access port and contaminate the patient as well as the surrounding area. In addition to creating a biohazard, such a situation could result in loss of fluids that are needed to monitor the health of the patient.
A further problem with existing stopcocks is that the diameter of the passageway formed through the stopcock is typically smaller the diameter of the lumen in the tube or catheter to which the stopcock is attached. As a result, the passageway of the stopcock impedes the fluid flow by creating a bottlenecking effect as the fluid tries to flow through the stopcock.
The present invention has been developed in response to the current state of the art, and in particular, in response to these, and other, problems and needs that have not been fully or adequately resolved by currently available valve apparatuses. Briefly summarized, embodiments of the present invention provide an improved valve apparatus which permits flushing of a drainage tube or catheter without necessitating the disconnection of the drainage tube or catheter from the patient or from the drainage bag, and which is suitable for use in conjunction with various medical instruments such as are typically employed to perform diagnostic, analytic, therapeutic, and other procedures.
Embodiments of the present invention are well suited for use in the context of the flushing of catheters, drainage tubes, and the like. However, it will be appreciated that embodiments of the present invention are suitable for use in any application or environment where it is desired to drain materials from a fluid source, aspirate material from a desired location, and/or introduce various materials to a desired location, in a simple and effective manner.
In one embodiment of the present invention, a valve apparatus is provided that includes a housing having proximal end, which includes a barb configured to mate with various standard catheters and drainage tubes, and a distal end. The housing further defines a passageway therethrough, and includes an access port defining a bore arranged for fluid communication with the passageway. A plunger, preferably comprising nylon or the like and having a bulb on the bottom and defining a flushing passage aligned with the bore, is slidingly disposed in the bore for reciprocal motion between an open and closed position, and at least partially resides within a sealing ring, having a plurality of wiper rings in contact with the plunger, also disposed in the bore. Both the plunger and sealing ring are securely retained within the bore by way of a first fitting, configured to mate with various standard medical devices such as syringes and the like, which defines a passageway in fluid communication with the bore and which engages corresponding retention tabs located on the housing. The first fitting further includes a shoulder so as to limit the upward range of motion of the plunger, slidingly received within the passageway defined by the fitting.
Disposed within the housing at its distal end is a hollow insert, preferably comprising a resilient material such as silicone or the like, and arranged so that a least a portion of the insert is disposed beneath the bore defined by the access port. The insert includes a flange that resides in a seat defined by the housing. Finally, a second fitting, preferably identical to the first fitting, is configured to be received within the insert and defines a passageway in communication therewith. The second fitting additionally includes a seat which contacts the flange of the insert when the second fitting is attached to the distal end of the housing.
During assembly, the sealing ring is disposed in the bore so that it contacts the seat defined within the bore. The plunger is then inserted into the bore and at least partially received by the sealing ring. The first fitting is attached to the access port and serves to compress the sealing ring onto the seat defined by the bore so as to substantially prevent leakage past the plunger. The insert disposed beneath the bore serves, by virtue of its resilience, to bias the plunger into an xe2x80x9copenxe2x80x9d position wherein the lower end of the flushing passage defined by the plunger is not aligned with the proximal end of the passageway of the housing, and wherein fluid is free to flow between the distal and proximal ends of the passageway. At the distal end of the housing, attachment of the second fitting causes the seat of the second fitting to contact and compress the flange of the insert, so as to substantially preclude leakage past the sides of the insert.
In operation, a syringe or other medical device attached to the first fitting acts to push the plunger down to the xe2x80x9cclosedxe2x80x9d position wherein the lower end of the flushing passage is aligned with the proximal end of the passageway defined by the housing so that fluids introduced by the medical device may pass freely through the flushing passage and out of the valve apparatus by way of the proximal end of the passageway. Also, when the plunger is moved to the xe2x80x9cclosedxe2x80x9d position by the medical device, the bulb on the bottom of the plunger serves to compress the portion of the insert disposed beneath the bore and thereby acts to substantially prevent fluid flow between the proximal and distal ends of the passageway. Upon removal of the medical device, the insert serves to bias the plunger back up into the xe2x80x9copenxe2x80x9d position.
In one embodiment of the invention, a medical instrument, such as an endoscopic device or guide wire, is disposed within the passageway and passes through the passageway and the catheter to which the valve apparatus is connected, and into the patient. Because the insert is resilient, it seals the passageway around the instrument during the flushing procedure. Accordingly, there is no need to remove the instrument in order to implement flushing of the catheter.
Embodiments of the present invention are thus effective in, among other things, permitting catheter flushing procedures to be performed without necessitating the disconnection of any of the elements of the catheter flushing and drainage system. Further, embodiments of the present invention are well suited for use in conjunction with various other medical procedures involving the use of instruments such as endoscopic devices, guide wires, and the like.
These and other objects and features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter.